Regulatory Affairs Analyst I

Profile

Regulatory Affairs Analyst I
Duties: Supports the department in interactions with other departments and FDA and other regulatory bodies by fulfilling all relevant regulatory bodies’ requirements through the provision of documentation to ensure the tobacco product business meets statutory requirements for operation in a regulated industry. Determines required information and resource deployment needs, manages the document and information collection process, and collaborates with department heads to ensure complete regulatory filings. Drives, supports and reviews the collection and compilation of data and documents for tobacco products, and presents finished work product for approval to Manager, including all documents and operational data required for compliance with regulatory submissions for pre-market registrations and filings within areas of responsibility; and, supports the projects required to ensure submission to relevant department heads all post-market reports responding to questions or providing additional information to regulators as needed. Provides substantive input in the development of the corporate Regulatory & Scientific Affairs policies, communication plan, process information, and corporate Standard Operating Procedure (SOP) documents; and oversees the process resulting in training materials through engagement with internal and outside parties (outside counsel); assists with the delivery of relevant Compliance training for all product lines, occasionally taking the role of the lead trainer; oversees the compilation of the documents to be used in training to further the development and efficient operation of the Compliance organization. Interact internally with professional staff in Product Integrity and Compliance, Operations, Marketing, and the Legal departments to obtain relevant information about new products, revised regulatory requirements, and filing documentation, which the incumbent is accountable for. Manages assigned projects independently, performs, monitors, and reports on such assigned projects by engaging with relevant departments, coordinating the compilation of relevant documents and information in support of regulatory filings, and reports submitted to senior management. Interacts internally with professional staff in QProduct Integrity and Compliance, Operations, Marketing, and the Legal departments to obtain relevant information related to new products, revised regulatory requirements, and filing documentation, which the incumbent is accountable for. Supports the development of the regulatory compliance database and regulatory communications and maintains the data and approval with scheduled updates to ensure accurate and current regulatory compliance information. Maintains current knowledge of tobacco product regulations, including proposed and final rules relevant to the tobacco industry position and regulatory trends as they become public. Researches press releases and pertinent news articles involving FDA or other regulatory bodies that may impact the tobacco industry. Prepares the schedule of required regulatory reporting of various monthly, quarterly and annual reports for submissions to agencies, manages the internal information and resources collection process on behalf of Regulatory & Scientific Affairs, responds to agencies’ questions regarding product information or issues as needed, and ensures schedules and interpretations of required submission data meet current regulatory requirements. Provides advisory input in departmental operational budget and input into the R&SA budget as it pertains to state certification according to historical knowledge of departmental needs.

Company info

Sign Up Now - EmploymentCrossing.com